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← All trials/NCT07915609

RecruitingPhase 3

A Study to Learn About Berobenatide Given Once Weekly in Adults With Knee Osteoarthritis and Overweight or Obesity With or Without Type 2 Diabetes (VESPER-OA 2)

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-WEEKLY BEROBENATIDE IN ADULTS WITH KNEE OSTEOARTHRITIS AND OVERWEIGHT OR OBESITY WITH OR WITHOUT TYPE 2 DIABETES (VESPER-OA 2)

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

4

Recruiting sites

1

Estimated enrollment

756

Study population

Obesity / overweight, Osteoarthritis, Type 2 diabetes

Eligibility highlights

•BMI ≥27

Primary endpoint

•Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07915609
Org study IDC6491023
Secondary ID2026-527180-15-00CTIS (EU)
Secondary IDVESPER-OA 2Alias Study Number

Timeline

Milestones

Study start2026-10-26actual
Study first posted2026-11-04actual
Last update posted2026-11-04actual
Primary completion2028-08-21estimated
Study completion2028-10-30estimated

Assets

Investigational agents

MET097 / PF-08653944

Who this study enrolls

Obesity / overweightOsteoarthritisType 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Adults 18 years of age or older, or the minimum age of consent according to local regulations.
•Body mass index of at least 27 kg/m² at Screening.
•Currently meets American College of Rheumatology (ACR) Criteria for knee OA.
•Pain due to knee OA.
•Knee radiograph consistent with knee osteoarthritis and Kellgren-Lawrence Grade 2 or 3.
•Willingness to complete the required analgesic washout.
•History of at least 1 self-reported unsuccessful dietary effort to lose body weight.

HbA1c value at Screening of:

1. <6.5% (48 mmol/mol) for participants without T2D

2. ≥6.5% (48 mmol/mol) and <10.0% (86 mmol/mol) for participants with T2D

Exclusion criteria

•Self-reported body weight increase or decrease greater than 5% within 90 days before Screening.
•For participants with T2D at Screening only:

• Diabetic maculopathy, proliferative diabetic retinopathy, or severe non-proliferative diabetic retinopathy requiring immediate intervention

•Known clinically significant gastric-emptying abnormality, history of acute or chronic pancreatitis, or active symptomatic gallbladder disease.
•Personal history or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
•Significant active or unstable psychiatric disorder.
•Condition or knee disorder that could confound assessment of target-knee pain
•Prior target-knee replacement, planned target-knee replacement, or planned elective knee surgery during the study.
•Recent use of weight-loss medication, any glucose-lowering therapy, or other protocol-prohibited treatment.
•Prior participation in a berobenatide clinical trial with receipt of active treatment or placebo.
•Hypersensitivity to a drug with glucagon-like peptide-1 receptor activity, including berobenatide, or any excipient.

Endpoints (42)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
18
Cardiometabolic biomarkers
9
Patient-reported / QoL
6
Safety / tolerability / PK
5
Weight & body composition
3
Glycemic / diabetes
1

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Percent change from baseline in Body Weight

Time frame:Baseline and Week 52

percent change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Body Weight

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index

Time frame:Baseline and Week 52

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change from Baseline in HbA1c (%) (T2D participants only)

Time frame:Baseline and Week 52

change from baseline, improvement

Cardiometabolic biomarkers

9 endpoints
Secondary/protocol endpoint

Change From Baseline in High-Sensitivity C-Reactive Protein

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure (DBP)

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Total Cholesterol

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in High-density lipoprotein cholesterol (HDL-C)

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Non-HDL Cholesterol

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Triglycerides

Time frame:Baseline and Week 52

change from baseline, improvement

Patient-reported / QoL

6 endpoints
Secondary/protocol endpoint

Change from baseline in SF-36 domain scales and component summary scales

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Reporting Improvement in Patient Global Impression of Severity (PGI-S) for knee-OA related physical function

Time frame:Baseline and Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Reporting Improvement in Patient Global Impression of Severity (PGI-S) for knee-OA pain

Time frame:Baseline and Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) for knee-OA related physical function

Time frame:Baseline and Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Reporting Improvement in Patient Global Impression of Change PGI-C for knee-OA pain

Time frame:Baseline and Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score

Time frame:Baseline and Week 52

change from baseline, improvement

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Number of participants with Treatment Emergent Adverse Events (TEAEs)

Time frame:Baseline and Week 52

event count, event

Secondary/protocol endpoint

Number of Participants with Serious Adverse Events (SAE)

Time frame:Baseline and Week 52

event count, event

Secondary/protocol endpoint

Number of Participants with AE leading to permanent discontinuation from study intervention or study

Time frame:Baseline and Week 52

event count, event

Secondary/protocol endpoint

Number of Participants with Adverse Events of Special Interest (AESI)

Time frame:Baseline and Week 52

event count, event

Secondary/protocol endpoint

Number of Participants with Clinical laboratory abnormalities

Time frame:Baseline and Week 52

event count, event

Other (unclassified)

18 endpoints
Primary/protocol endpoint/low confidence

Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in WOMAC Physical Function Subscale score

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of participants with ≥50% reduction in the WOMAC pain subscale score

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of participants with ≥30% reduction in the WOMAC pain subscale score

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Proportion of participants with utilization of protocol specified pain medication during the washout period

Time frame:Baseline and Week 52

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Amount of protocol specified pain medication during the washout period

Time frame:Baseline and Week 52

descriptive

Secondary/protocol endpoint/low confidence

Change from baseline in WOMAC stiffness score

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in WOMAC total score

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Proportion of participants achieving ≥50% reduction in the WOMAC physical function subscale score

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Proportion of participants meeting OMERACT-OARSI

Time frame:Baseline and Week 52

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in Average Pain Intensity-Numerical Rating Score

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in Worst Pain Intensity -Numerical Rating Score

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in timed walking distance at Week 52

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in WPAI:GH Presenteeism Score

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in WPAI:GH Work Productivity Loss Score

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in WPAI:GH Activity Impairment Score

Time frame:Baseline and Week 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.